APRIL 2007

WEEK ENDING APRIL 7

PRODUCT
a) RF Denervation Probe, 5cm, temperature sensing electrodes designed for
use in radiofrequency lesion procedures for the treatment of pain.
Part Number: 7210270, 
b) RF Denervation Probe, 10 cm, temperature sensing electrodes designed
for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210271, 
c) RF Denervation Probe, 15 cm, temperature sensing electrodes designed
for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210272, 
CODE
a) Lot Numbers: 602549,602550, 602846, 602847;
b) Lot Numbers: 602541, 602542, 602556, 602557, 602558, 602559,
602560, 602561, 602562, 602848, 602849, 602999;
c) Lot Numbers: 602543, 602570, 602571, 602850, 603000
RECALLING FIRM/MANUFACTURER Smith & Nephew, Inc., Endoscopy Div., Andover, MA
REASON Product is non-sterile but labeled incorrectly as sterile.
VOLUME OF PRODUCT IN COMMERCE 497 units
DISTRIBUTION Nationwide and Internationally

PRODUCT CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, 
CODE Lot Numbers: 1091612, 1091712, 1091812, 1091912, 1092012, 1092112
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA
REASON Incorrect Test Results. Product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that is unacceptable (out-of-range).
VOLUME OF PRODUCT IN COMMERCE 9,800 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272518,
b) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272519,
c) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272520,
d) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521,
e) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272522,
CODE
a) Lot 97000414;
b) Lot 97000415;
c) Lot 97000416;
d) Lot 97000417;
e) Lot 97000418
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN.
REASON The device was cut to an incorrect angle, which may result in an incorrect bone cut.
VOLUME OF PRODUCT IN COMMERCE 5 devices
DISTRIBUTION MI

PRODUCT Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, 
CODE All units. Version 5.0
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, USA, Inc., Ann Arbor, MI
REASON The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.
VOLUME OF PRODUCT IN COMMERCE 62 units
DISTRIBUTION Nationwide

PRODUCT
a) Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only,
Rx only, 
b) Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only,
Rx only, 
CODE
a) Lot Nos.: 42554, 59143, 74708, 076380, 076520, 81321, 82118,
82119, 82236, 83602, 83667, 98552, 177390, 177420, 229470,
230050, 365740, 662340, 685000, 857100, 877430, 909610,
W05A1351, W05C5778, W05F5388, W05F5389, W05G1030,
W05G2592, W05H1354, W05H7884, W05J1023, W05J1497,
W05J1687, W05J2710, W05J2711, W05L0550, W05L1016,
W06E3829, W06F4111, W06H1671, W06K1299, W06M1486,
W06M1487;
b) Lot Nos.: W04E0149, W04C1938, 553880, 672660, 353150,
355610, 201190, 198840, 947250, 914870, 82549, 81749, 81320,
76967, 65867, 42841, 42842
RECALLING FIRM/MANUFACTURER Medtronic Sofamor Danek USA Inc., Memphis, TN,
REASON Bone screws may pull though the plate.
VOLUME OF PRODUCT IN COMMERCE 1700 units
DISTRIBUTION Internationally

PRODUCT
a) Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000;
Catalog No. 16400, 
b) Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000;
Catalog No. 16401, 
c) Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000;
Catalog No. 16405, 
d) Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000;
Catalog No. 16406, 
e) Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000;
Catalog No. 16410, 
CODE
a) Hand crank serial numbers 1240 through 1247;
b) Hand crank serial numbers 1963 through 1986;
c) Hand crank serial numbers 1285 through 1306;
d) Hand crank serial numbers 1197 through 1214;
e) Hand crank serial numbers 1621 and 1622
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI
REASON The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
VOLUME OF PRODUCT IN COMMERCE 85 units
DISTRIBUTION Nationwide and Internationally

PRODUCT 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04,
CODE Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected: 0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73
RECALLING FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA, 
REASON The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION Nationwide and Internationally

PRODUCT MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer, 
CODE Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
RECALLING FIRM/MANUFACTURER Sonosite, Inc., Bothell, WA
REASON Laparoscopic ultrasound transducer exceeds the limits specified for radio-frequency emissions by up to 10db.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0, 
CODE Lot: 1820419
RECALLING FIRM/MANUFACTURER Cook, Inc., Bloomington, IN, REASON Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
VOLUME OF PRODUCT IN COMMERCE 20 devices
DISTRIBUTION Nationwide

PRODUCT
a) superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract, 
b) Disposable components of the superDimension Bronchus System: Locatable
Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01),
CODE
a) Serial numbers: S0030019, S030051, S030052, S030054, S030055,
S030058 thru S030062, S030067, S030068, S030077 thru S030081;
S030084, S030085, S030088 thru S030095; S030097 thru S030100,
S030103, S030104, S030105, S030390, S030447, S030449, S0030009,
S0030011, S0030013, S0030014, S0030015, S0030021, S0030022,
S0030026, S0030042, S030043 thru S030050, S030053, S030056,
S030057, S030063, S030064, S030066, S030069 thru S030076, S030082,
S030086, S030087, S030096, S030102, S030477;
b) All codes of disposable system components
(Locatable Guide and Extended Working Channel)
RECALLING FIRM/MANUFACTURER
Recalling Firm: superDimension, Inc. Minneapolis, MN.,
Manufacturer: Superdimension, Ltd., Herzliya, Israel. 
REASON The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
VOLUME OF PRODUCT IN COMMERCE 74 Bronchus Systems, 2,000 each of the disposable components
DISTRIBUTION Nationwide and Internationally

PRODUCT Matrix2 Detachable Coils, for embolization of intracranial aneurysms. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 494203, UPN: M0034942030,
CODE Batch numbers: 8941830 and 8852539
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Target., Fremont, CA.
Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. 
REASON The product may be missing the temperature indicator label on the inner pouch.
VOLUME OF PRODUCT IN COMMERCE 57 units
DISTRIBUTION Nationwide and Internationally

PRODUCT BD™ Sensi-Disc™ Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, 
CODE Lot 6167435, exp 6/30/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD.
Manufacturer: Becton Dickinson Caribe LTD, Cayey, PR.
REASON Antibiotic susceptibility testing reagent was not manufactured according to specifications and may cause ineffective treatment regimen in patients with infections. The recalling firm received customer reports of false susceptibility results.
VOLUME OF PRODUCT IN COMMERCE 528/10 packs
DISTRIBUTION Nationwide and Internationally

PRODUCT Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm, 
CODE System Numbers: SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.
RECALLING FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA.
REASON Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
VOLUME OF PRODUCT IN COMMERCE 24 units
DISTRIBUTION Nationwide

PRODUCT LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries. Affected part numbers: 3200731-000, 002, 006, 020 through 025, 040, 042, 043, 060, 062, 063, 080 through 084, 102, 103, 104, 120, 122, 124, 125, 140, 143, 145, 160, 163, 180, 182, 183, 202, 203, 222, 223, 242, 260, 261, 263, 282, 284, 400 and 403, and U3200731-002,
CODE
Serial Numbers: 31269543, 31188518, 31271729, 31280480, 31311486, 31682955, 31272026, 31272027, 31188516, 31429363, 30558817, 30540859, 31266744, 31395897, 30943076, 30943001, 30943052, 30943055, 30943065, 30943061, 31244729, 31312681, 31312683, 31305314, 30943073, 30943074, 30942993, 31401299, 30943265, 30943267, 30943269, 30943064, 30943059, 30943054, 30558822, 30943023, 30943021, 30943020, 30943019, 30943018, 30943006, 30943011, 31400288, 31415717, 31389380, 31389382, 31389384, 31389385, 31389386, 31389387, 31389389, 31389390, 31389391, 31389392, 31389467, 31389468, 31036207, 31036229, 31036234, 31036268, 31508665, 31508724, 31508757, 31508769, 31508781, 31729699, 31757625, 31758075, 31758090, 31758114, 31758115, 31758132, 31758164, 31758996, 31335474, 31335476, 31335478, 31335480, 31335481, 31335483, 31335484, 31335487, 31335491, 31269004, 31679120, 31270599, 31271030, 31273782, 31273787, 31273790, 31273817, 31273819, 31273822, 31271038, 31273839, 31273861, 31273874, 31271037, 31273884, 31273885, 31174536, 31508775, 31268954, 31269001, 31188476, 31416439, 31266757, 31266811, 31266812, 31416440, 31174528, 31174532, 30972193, 31441727, 31441728, 31441729, 30888563, 30941563, 31319302, 31319303, 31203500, 31335188, 30848721, 30848792, 30848796, 30848797, 30848801, 30848835, 30848850, 30848865, 30849171, 30849174, 30849176, 30849180, 30849183, 30849184, 30849186, 30849187, 30849189, 30849190, 30849191, 30849193, 30849195, 31176927, 31254373, 31254375, 31255892, 31341356, 31341446, 31341474, 31341478, 31725119, 31271759, 31266749, 30913596, 31174308, 31434956, 30888511, 31179993, 31179994, 31319297, 30558878, 31335477, 31028905, 31508714, 31240363, 31036145, 31036149, 31039891, 31039893, 31811260, 31677434, 31677435, 31677436, 31677437, 31636161, 31636164, 31636165, 31636166, 31636168, 31636169, 31636170, 31636171, 31636172, 31636173, 31636174, 31636175, 31636176, 31636177, 31636178, 31636480, 31773379, 31203487, 31256714, 30558965, 31422465, 31422466, 30558800, 31036198, 31036209, 31036257, 31036281, 31508689, 31508808, 30558978, 31312853, 31028889, 31508694, 31028289, 31462210, 30558988, 30848829, 31268965, 30540791, 30540852, 30540853, 30540858, 30540860, 30540865, 30540866, 30558821, 30558833, 30558848, 30558996, 31335486, 30849188, 31266696, 31247174, 31271724, 31271728, 31307077, 30558910, 31000816, 31305367, 31305368, 31350759, 31386272, 30913599, 30849170, 31247167, 31758928, 31509066, 31028324, 31036274, 30848719, 31313298, 30888509, 31508711, 31692816, 31000915, 30558799, 31247164, 31028910, 31266695, 30913557, 31319292, 31319312, 31319314, 31036269, 31319319, 30558985, 31036288, 30558924, 31179983, 31179984, 31179987, 30698128, 30698129, 30698130, 30698131, 30698132, 30698133, 30698134, 30698136, 30888517, 31508780, 31508787, 31508790, 30888493, 31247169, 30558939, 30888503, 30888499, 31319308, 31247180, 31000755, 31508659, 30991159, 31332304, 31268948, 30913600, 31508782, 31259904, 31247158, 31174298, 30996459, 30996461, 30996462, 30996463, 30996464, 30996465, 30996466, 30996467, 30996468, 31312757, 31342150, 31342182, 31342183, 31342254, 31481822, 31023273, 31292563, 31203486, 31434943, 31434944, 31434948, 31434949, 31434951, 31434952, 31434953, 31434954, 31434955, 30558994, 30558999, 31757985, 31268988, 30774968, 31023432, 31624102, 30783380, 31247173, 31268985, 31335182, 30849185, 30913605, 31758029, 31266746, 31685960, 31268998, 31036233, 30558998, 31260325, 30540787, 30540862, 31437697, 31508786, 30888502, 30558814, 31269042, 31305345, 30558864, 31266594, 30848873, 31000842, 30558987, 30558929, 31524334, 31524641, 31268950, 30540834, 31319309, 31268961, 30888546, 31305312, 31000914, 31269041, 30880773, 31796392, 31247168, 31319293, 31174539, 31387963, 31405736, 31405739, 31470265, 31485850, 31202868, 31202869, 31758007, 31758026, 31178474, 30972383, 31335169, 31335174, 31335175, 31335176, 31335187, 31335189, 31335190, 31335192, 31247151, 31485821, 31387952, 31508662, 31508728, 31508747, 31389395, 30849175, 31000827, 31188477, 31188480, 31188482, 31188483, 31188486, 31188490, 31188497, 31188503, 31188504, 31188505, 31188509, 31188510, 31188511, 31203505, 31203506, 31203507, 31203508, 31203509, 31203511, 31203512, 31203513, 31247150, 31247152, 31264440, 31264489, 31264500, 31264502, 31264503, 31264504, 31264505, 31264506, 31264508, 31264512, 31264513, 31264515, 31264518, 31264520, 31264521, 31264878, 31268942, 31268945, 31268946, 31268947, 31268951, 31268956, 31268971, 31268981, 31268983, 31268987, 31268991, 31269008, 31269009, 31269028, 31269033, 31269034, 31269035, 31269039, 31269043, 31269052, 31319299, 31319307, 31319315, 31416416, 31416436, 31416437, 31416441, 31028276, 31036188, 31036193, 31036195, 31036235, 31028201, 31028208, 31028270, 31036212, 31036218, 31036227, 31508656, 31508661, 31508682, 31508686, 31508698, 31508701, 31508703, 31508705, 31508707, 31508709, 31508733, 31508749, 31508751, 31508759, 31508765, 31508801, 31508806, 31509054, 31509060, 31757916, 31757917, 31757924, 31757927, 31757945, 31757981, 31757987, 31757989, 31758006, 31758015, 31758031, 31758046, 30558916, 30558925, 31359230, 31359252, 31359254, 31359229, 31508741, 31000882, 31028903, 31437690, 31437691, 31437692, 31437693, 31437694, 31437695, 31437696, 31437698, 31179989, 31319311, 31247147, 30941567, 31270562, 30880776, 31000841, 31000843, 31000844, 31000845, 31000878, 31000892, 31179998, 31508699, 31508722, 31508729, 31000773, 30535064, 30888505, 30559031, 31028886, 31174193, 30888539, 30880769, 30880770, 30880771, 31269059, 31319290, 31319291, 31319320, 30558839, 31266742, 31344933, 31345458, 31508678, 30990981, 30905391, 30909781, 31178386, 31036255, 31305353, 31677433, 31509064, 31513690, 31205197, 31759128, 31485330, 31508744, 31258799, 31313396, 31313397, 31313601, 31313602, 31313604, 31205300, 31338330, 31338331, 31341569, 31341571, 31341572, 31346964, 31347000, 31816901, 31205172, 31462170, 31205128, 31401174, 31342149, 31264385, 31333111, 31176069, 31344231, 30684352, 31336943, 31336944, 31026980, 31358993, 31022531, 31720176, 31720205, 31720240, 31754470, 31754472, 31754475, 30560647, 30782811, 30782819, 30783486, 31028224, 31662013, 31772510, 31767696, 31759118, 31759119, 31520033, 30558901, 30558948, 31662066, 31662070, 31255045, 31184904, 31408848, 31408849, 31409949, 31409950, 31462962, 31462966, 31462976, 31462979, 31648966, 31763534, 30780047, 30774847, 30774963, 31358901, 31358902, 31647560, 31647564, 31259425, 31524644, 31178373, 31178374, 31178375, 31178376, 31178377, 31425294, 31425296, 31425297, 31425298, 31425299, 31519920, 31509069, 31758950, 31259370, 30771069, 31036201, 30762761, 31336940, 31336941, 31336942, 31036231, 31269562, 31269563, 31269567, 31269569, 31269570, 30946867, 31814503, 31265849, 31746117, 31557413, 31557419, 31268073, 31179907, 31036265, 31512622, 31565941, 31565942, 31512627, 31494888, 31519996, 31511859, 31281568, 31281571, 31281572, 31281573, 30737177, 31186426, 31713264, 31435688, 31758744, 31758753, 31758801, 31758804, 30540774, 30946892, 30946893, 30946905, 31311736, 31470986, 31470987, 31260666, 31313607, 30895511, 30893294, 31669938, 31671259, 31807954, 31807962, 30771146, 30771150, 30771151, 30771153, 31448026, 31758844, 31185841, 30771090, 31550402, 30475348, 31329925, 31329926, 31329927, 31329928, 30475366, 31278293, 31278594, 31278596, 31278600, 31278601, 31278602, 31278603, 31278604, 31278605, 31278606, 31278608, 31278609, 31278610, 31278611, 31278612, 31278613, 31278615, 31278616, 31278617, 31278618, 31278619, 31278620, 31278621, 31278622, 31278623, 31278624, 31278625, 31278626, 31278629, 31278630, 31278631, 31278632, 31278633, 31278634, 31280478, 31280479, 31358300, 31205129, 31662464, 31661750, 31661751, 31661752, 31661754, 31661758, 31661762, 31811430, 31256620, 31349888, 31466774, 31270780, 31270781, 31720217, 30905427, 31316523, 31431041, 30905334, 30905400, 30905407, 30905432, 30909680, 30909786, 30909791, 30909824, 30910104, 31255049, 31185851, 31379999, 31385110, 31259830, 31259831, 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RECALLING FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond, WA.
REASON LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.
VOLUME OF PRODUCT IN COMMERCE 13,835 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, 
CODE Lot: 063533
RECALLING FIRM/MANUFACTURER Remington Medical, Inc., Alpharetta, GA
REASON Pouches were not sealed prior to sterilization.
VOLUME OF PRODUCT IN COMMERCE 192 units
DISTRIBUTION Nationwide

PRODUCT Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00, 

CODE Lot: 60605829
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN
REASON The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.
VOLUME OF PRODUCT IN COMMERCE 21 units
DISTRIBUTION Nationwide

PRODUCT Swiss Lithocast Ultra Ultrasound Handpiece (EMS-PN: EL-236) used in combination with Swiss Lithoclast Ultra System,
CODE Units manufactured prior to January 2003.
RECALLING FIRM/MANUFACTURER E.M.S. – Electro Medical Systems SA, Nyon, Vaud, Switzerland, by letter on April 22, 2005. Firm initiated recall is ongoing.
REASON Handpiece may become dislodged causing cable damage and possible electric shock.
VOLUME OF PRODUCT IN COMMERCE 160 units
DISTRIBUTION Nationwide

PRODUCT Plicator EPS Plication System, Catalog Number: 160-01128R, CODE Serial numbers: 43, 52, 54, 59, 63, 65, 68, 72, 96
RECALLING FIRM/MANUFACTURER NDO Surgical, Inc., Mansfield, MA,
REASON Device arm may fail to open after being deployed and require surgical intervention to remove.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Aspyra, Inc. CyberMed Version 2.1 Pharmacy Software
CODE Version 2.1
RECALLING FIRM/MANUFACTURER Aspyra, Inc., Calabasas, CA, REASON Medications prescribed for one patient were printed on the Medication Administration Record (MAR) of another patient.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION Nationwide

PRODUCT
a) Product Description: HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system),
b) HTA Console System, 230 Volt, English, Product Number: 560010
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), 
c) HTA Console System, 230 Volt, Product Number: 56001 DO- English
Demonstration Evaluation Unit (HTA system is a software-controlled
hysteroscopic thermal endometrial ablation system), 
d) HTA Console System, 230 Volt , French, Product Number: 56001FO
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), 
e) HTA Console System, 230 Volt , Italian, Product Number: 56001 IO
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), 
CODE
a) Unit Numbers: N1190JC, N1191JC, N1192JC, N1194JC, N1197JC, N1199JC, N1200JC, N1201JC, N1203JC, N1204JC, N1205JC, N1206JC, N1208JC, N1210JC, N1211JC, N1214JC, N1215JC, N1217JC, N1218JC, N1220JC, N1222JC, N1226JC, N1227JC, N1229JC, N1230JC, N1231JC, N1232JC, N1233JC, N1234JC, N1235JC, N1237JC, N1238JK, N1239JF, N1240JF, N1241JF, N1242JF, N1243JF, N1245JF, N1247JF, N1251JF, N1252JF, N1253JF, N1254JF, N1255JF, N1257JF, N1258JF, N1259JF, N1261JF, N1262JF, N1263JF, N1264JF, N1266JF, N1267JF, N1268JF, N1269JF, N1294JI, N1295JI;
b) Unit Numbers: IN0335JC, IN0337JC, IN0341JD, IN0342JD, IN0343JD,
IN0344JE, IN0345JE, IN0347JE, IN0348JE, IN0349JE, IN0352JG,
IN0353JG, IN0355JG, IN0356JG;
c) Unit Numbers: IN0335JC, IN0344JE, IN0345JE, IN0349JE, IN0352JG,
IN0353JG, IN0355JG, IN0356JG;
d) Unit Numbers: IN0350JG, IN0351JG;
e) Unit Numbers: IN0339JC, IN0340JC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA., 
Manufacturer: Nexcore Technology, Inc., Waldrick, NJ. 
REASON Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment.
VOLUME OF PRODUCT IN COMMERCE 51 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, 
CODE Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO.
Manufacturer: Gambro Lundia Ab - Disposables Division, Lund, Sweden. REASON Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
VOLUME OF PRODUCT IN COMMERCE 153 units
DISTRIBUTION Nationwide

PRODUCT
a) Boston Scientific SpyGlass Visualization Probe Reference Number: 4603,
UPN M00546030, 
b) Boston Scientific SpyGlass Ocular Reference Number: 4604,
UPN M00546040,
c) Boston Scientific SpyGlass Light Cable Reference Number: 4621
UPN M00546210, 
d) Boston Scientifica SpyGlass Camera Ref Number: 4610
UPN M00546100, 
CODE
a) Lot number: 527301, 527302, 533202, 625401, 628902, 63001,
633201, 635501, 702901;
b) Lot Number: 532202;
c) Lot Number: 355R;
d) Lot Numbers: 061005, 061006, 061007, 061009, 061010, 0161011,
061012, 610130, 61014, 061015, 0610106, 061017
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Natick, MA, 
REASON SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
VOLUME OF PRODUCT IN COMMERCE 115 units
DISTRIBUTION Nationwide

PRODUCT InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body),
CODE InstaTrak 3500 Plus systems with version 5.1 software. The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems,Inc., Salt Lake City, UT, 
REASON Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
VOLUME OF PRODUCT IN COMMERCE 91 units
DISTRIBUTION Nationwide and Internationally

PRODUCT BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618, 
CODE Lot Number: 6181868
RECALLING FIRM/MANUFACTURER BD Opthalmic Systems, Waltham, MA.,
REASON Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
VOLUME OF PRODUCT IN COMMERCE 1,500 units
DISTRIBUTION Nationwide

PRODUCT The Precision Implantable Pulse Generator, Model Number SC-1110, 
CODE
161773, 161898, 161934, 161969, 160753, 102331, 103463, 103497, 103525, 160041, 160077, 160080, 160088, 160090, 160091, 160092, 16009, 160096, 160103, 160104, 160105, 160107, 160108, 160110, 160113, 160115, 160141, 160142, 160144, 160146, 160602, 161028, 161065, 161222, 161350, 161415, 161425, 161430, 161457, 161484, 161497, 161508, 161579, 161644, 161658, 161674, 161680, 161681, 161700, 161751, 161760, 161790, 161807, 161840, 161853, 810024, 810051
RECALLING FIRM/MANUFACTURER Advanced Bionics Corp., Sylmar, CA, 
REASON The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
VOLUME OF PRODUCT IN COMMERCE 5 unimplanted units; 52 implanted units
DISTRIBUTION Nationwide and PR

WEEK ENDING APRIL 14

PRODUCT Medical Air Compressor, Model # 8413419,
CODE Serial Numbers ARXC-001; ARXC-0002; ARXC-0009; ARXC-0011; ARXC-0012; ARXC-0013; ARXC-0014; ARXC-0015; ARXC-0016; ARXC-0017; ARXC-0019; ARXC-0020; ARXD-0034; ARXD-0035; ARXD-0036; ARXD-0037; ARXD-0038; ARXD-0039; ARXD-0040; ARXE-0081; ARXE-0082; ARXE-0083; ARXE-0084; ARXE-0085; ARXE-0086; ARXE-0087; ARXE-0088; ARXE-0089; ARXE-0090; ARXE-0091; ARXE-0092; ARXE-0093; ARXE-0094; ARXE-0095; ARXE-0096; ARXE-0097; ARXE-0098; ARXE-0099; ARXE0100; ARXE-0101; ARXE-0102; ARXE-0103; ARXE-0104; ARXE-0106; ARXE-0107; ARXE-0108; ARXE-0109; ARXE-0110; ARXE-0111; ARXE-0112; ARXE-0113; ARXE-0114; ARXE-0115; ARXE-0116; ARXE-0117; ARXE-0118; ARXE-0119; ARXE-0120; ARXE-0121; ARXE-0122; ARXE-0123; ARXE-0124; ARXE-0125; ARXE-0126; ARXE-0127; ARXE-0128; and ARXE-0129
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA.
Manufacturer: Draeger Medical AG & Co., KG, Lubeck, Germany. 
REASON Compressors not providing sufficient supply pressure to connected medical ventilator.
VOLUME OF PRODUCT IN COMMERCE 67 units
DISTRIBUTION Nationwide

PRODUCT Scanlan International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, 
CODE Lot: AZ115806
RECALLING FIRM/MANUFACTURER Scanlan International, Inc., Saint Paul, MN,
REASON Incorrectly assembled by manufacturer.
VOLUME OF PRODUCT IN COMMERCE 105 units
DISTRIBUTION Nationwide and Internationally

PRODUCT ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27, 
CODE There are no specific lot codes. The problem is associated only with customers that use the ''Safe Pico'' blood sampler in conjunction with the ABL800 analyzer.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH,
Manufacturer Address: Radiometer Medical ApS, Bronshoj, Denmark. 
REASON In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
VOLUME OF PRODUCT IN COMMERCE 1345 units
DISTRIBUTION Nationwide and Internationally

PRODUCT CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01, 7
CODE Lot Numbers: 1446512, 1559712, 1559812, 1675212, 1675312, 1675412, 1794312, 1794612, 1794712, 1794912, 1795012, 1795212, 1795312, 1795412, 1810712, 1810812, 1810912, 1811012
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA.,
REASON Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range.
VOLUME OF PRODUCT IN COMMERCE 27,411 units
DISTRIBUTION Nationwide and Internationally

PRODUCT CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems, List Number 01H73-01, 
CODE All lots.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA.
REASON High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results that are unacceptable-out-of-range.
VOLUME OF PRODUCT IN COMMERCE 56,075 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) ThermaSure Medical Device Drying Cabinet, series 130
Catalog #s 090035-00, 090035-03, 090036-00, 090036-02,
b) ThermaSure Medical Device Drying Cabinet, series 300,
Catalog #s: 090033-02, 090033-04, 090034-02, 090034-04,
c) ThermaSure Medical Device Drying Cabinet, series 1000,
Catalog #s: 090010-02, 090010-04, 090011-00, 090011-02,
CODE
a) Serial Numbers: 350305, 350306, 350307, 350308, 360309, 350310,
350311, 360312, 350313, 350314, 350401, 350402, 350403, 350404,
350405, 350406, 350407, 350408, 350409, 350410, 350411, 350412,
350413, 350414, 350415, 350416, 350417, 350418, 350419, 350420,
350421, 350422, 350423, 350424, 350425, 350426, 350427, 350501,
360502, 350503, 350504, 350505, 350506, 350507, 350508, 350509,
350510, 350511, 350512, 350513, 350514, 350515, 350516, 350517,
350518, 360519, 350520, 350521, 350522, 350523, 350524, 350525,
350526, 350527, 350528, 350529, 350530, 360531, 350532, 350533,
350534, 350601, 350602, 350603, 350604, 350605, 350606, 350607,
350608, 350609, 350610, 360611, 360612, 350613, 350614, 350615,
350616, 350617, 350618, 350619, 350620, 350621, 350621A, 350622,
350623, 350624, 350625, 350626, 350627, 350628, 350629;
b) Serial Numbers: 330304, 330305, 330306, 330307, 330308, 330309,
330310, 330311, 330312, 330313, 330401, 330402, 330403, 340404,
330405, 340406, 330407, 330408, 330409, 330410, 330411, 340412,
330413, 330414, 330415, 330416, 340417, 340501, 330502, 330503,
330504, 330505, 340506, 330507, 330508, 330509, 330510, 330511,
330512, 330601, 330602, 330603, 330604, 330605, 330606, 330607,
330608, 330609, 330610, 330611;
c) Serial Numbers: 100401, 100402, 100403, 100404, 100501, 100601,
100602, 100603
RECALLING FIRM/MANUFACTURER Cenorin, Kent, WA
REASON Potential for user to receive an electrical shock.
VOLUME OF PRODUCT IN COMMERCE 159 dryers
DISTRIBUTION Nationwide and Internationally

PRODUCT ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
CODE Lot: D632517
RECALLING FIRM/MANUFACTURER Integra Biotechnical LLC, Vista, CA,
REASON During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.
VOLUME OF PRODUCT IN COMMERCE 1,769 units
DISTRIBUTION Nationwide

PRODUCT Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu® Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl. oz., 12 fl. oz. and 16 fl. oz, 
CODE Lot numbers appearing on the bottles distributed in the U.S.: GCT6030, GC6037, GC6045, GC6061, GC6063, GC6072, GC6073 and GC6085. The lots all carry the expiration date ''2008-03'' on the bottle. Lot numbers appearing on bottles distributed only outside of the U.S.: GC6038, GC6048 and GC6052.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Rochester, NY, 
Manufacturer: Bausch & Lomb Inc., Greenville, SC. 
REASON A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
VOLUME OF PRODUCT IN COMMERCE 1.5 million units
DISTRIBUTION Nationwide and Internationally

PRODUCT QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine, 
CODE Serial numbers: 4605AU0251E, 2306AU0600E-BT, 2306AU0601E-BT, 2406AU0610E-BT, and 2706AU0641E-BT
RECALLING FIRM/MANUFACTURER Pulse Biomedical, Inc., Norristown, PA,
REASON No 510 (k) marketing clearance for the product.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION NY, NJ, Chile, Greece, and the Netherlands

PRODUCT BD 30ml Syringe Luer-Lok tip Sterile, Made in USA, Reorder number 309650, 
CODE Lot numbers 6188613, 6188614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ
Manufacturer: Becton Dickinson & Co., Columbus, NB. F
REASON The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.
VOLUME OF PRODUCT IN COMMERCE 332,400 units
DISTRIBUTION Nationwide

PRODUCT
a) Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic
urethra lengths of 3.0-5.0 cm only. Model TA1121D, 
b) Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic
urethra lengths of 2.5-3.5 cm only. Model TA1321D,
CODE
a) Individual Catheter lot numbers: M002671,M002672, M002589 and M002736. Kit box lot numbers: KP011206, KP053006B, KP053006C, KP060205, KP0011206;
b) Individual catheter lot number KG001346. Kit box lot number KGP111105
RECALLING FIRM/MANUFACTURER Urologix, Inc., Minneapolis, MN, 
REASON The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
VOLUME OF PRODUCT IN COMMERCE 117 kits
DISTRIBUTION Nationwide and the Netherlands

PRODUCT Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20,
CODE 42020HW00 and 44037HW00
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories Inc., South Pasadena, CA., 
Manufacturer: Microgenics Corp., Fremont, CA. 
REASON Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L).
VOLUME OF PRODUCT IN COMMERCE 1,665 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), 
CODE Lot: 33906 P5 and Lot: 63906 P5
RECALLING FIRM/MANUFACTURER Hamilton Co., Reno, NV., 
REASON Some of the packaged tips have increased force during aspiration, which can lead to pipetting errors such as LLD error messages, and also has risk of causing a missed pipetting.
VOLUME OF PRODUCT IN COMMERCE 37 cases
DISTRIBUTION NJ

PRODUCT
a) Smith & Nephew Suture Passer 12 inch, Part number: 7209166,
b) Smith & Nephew Suture Passer 12 inch, Part number: 7209166D,
(refurbished), 
c) Smith & Nephew Suture Passer 2 inch, Part number: 7209167,
CODE All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Div., Andover, MA
Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. 
REASON Product is labeled as reusable but there is a potential that the Cannulated handle of the product cannot be cleaned adequately following use.
VOLUME OF PRODUCT IN COMMERCE 12,292 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP); RX ONLY, CODE Serial numbers affected: 691099, 691108, 691117, 691700, 691704, 691713, 691719, 691724, 691729, 691731, 691734, 691737, 691739, 691744, 691748, 691756, 691761, 691764, 691769, 691772, 691776, 691780, 691785, 691788, 691793, 691794, 691798
RECALLING FIRM/MANUFACTURER Smiths Medical MD, Inc., Saint Paul, MN, 
REASON The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.
VOLUME OF PRODUCT IN COMMERCE 27 units
DISTRIBUTION Nationwide

PRODUCT ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); 
CODE Lot numbers 42462M100 and 42462M101
RECALLING FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park, IL,
REASON A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.
VOLUME OF PRODUCT IN COMMERCE 1,944 kits
DISTRIBUTION Nationwide and Internationally

WEEK ENDING APRIL 21

PRODUCT
a) AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile,
b) AMS DURA-II Universal Tips, 2 cm, Product Number 72009361, Sterile,
CODE
a) Lot: 475177;
b) Lot: 475175
RECALLING FIRM/MANUFACTURER American Medical Systems, Minnetonka, MN,
REASON Mis-Labeling. The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION Nationwide

PRODUCT Sea-Clens Wound Cleanser, 6 fl. oz., #11701-159-36, #1063, CODE Lot #932502, box sequence numbers 299 to 953.
RECALLING FIRM/MANUFACTURER Coloplast Corp Skin Care Division, North Mankato, MN,
REASON Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
VOLUME OF PRODUCT IN COMMERCE 7,848 6 fl. oz. bottles
DISTRIBUTION Nationwide

PRODUCT Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift), 
CODE Model number Hoy - Advance - E Serial numbers: 0601L0433 through 0601L0441, 0603L0294 through 0603L0336, 0603L0493 through 0603L0501, 0603L1011 through 0603L1021, 0603L1139 through 0603L1187, 0603L1285 through 0603L1294, 0604L0394 through 0604L0411, 0604L0885 through 0604L0941, 0604L1002 through 0604L1012, 0606L0365 through 0606L0431, 0606L0789 through 0606L0818, 0606L1006 through 0606L1030, and 0607L0001 through 0607L0090 

Model number Hoy - Advance - H Serial numbers: 0601L0442 through 0601L0459, 0603L0286 through 0603L0293, 0603L1022 through 0603L1041, 0603L1295 through 0603L1330, 0603L1519 through 0603L1572, 0605L0742 through 0605L0753, 0606L0049 through 0606L0142, 0606L0819 through 0606L0848, and 0606L1031 through 0606L1144
RECALLING FIRM/MANUFACTURER
Recalling Firm: Joerns Healthcare Inc., Stevens Point, WI
Manufacturer: Apex Health Care Mfg., Inc., Taiwan, Republic Of China. REASON Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).
VOLUME OF PRODUCT IN COMMERCE 581 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length,
Item Number: LXB10040, 
b) Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length,
Item Number: LXB10060, 
CODE
a) Lot Numbers: ANQJO636, ANQJO63;
b) Lot Number: ANQJ0639
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conmed Endoscopic Technologies, Inc., Billerica, MA, 
Manufacturer: Angiomed GmbH & Co., Karlsruhe, Germany. 
REASON Blue safety clip incorrectly placed on the stent may prevent deployment
VOLUME OF PRODUCT IN COMMERCE 12 units
DISTRIBUTION DE, OH, MI, DC, Belgium and Japan

PRODUCT Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; 
CODE DOA6120272
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Rad Laboratories Inc., Hercules, CA., 
Manufacturer: Inverness Medical Porfessional Diagnostics, San Diego, CA. REASON The product may produce a faint line which could be interpreted as a false negative test result.
VOLUME OF PRODUCT IN COMMERCE 177 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular
Diagnostics, 
b) AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular
Systems, Inc., 
CODE
a) US Distribution: Batches: H08499, H10626, H13592, J00807, J00815;
b) European Distribution: Batches: H08500, H13591, H14242, J00383, J00814
RECALLING FIRM/MANUFACTURER Roche Molecular Systems, Inc., Somerville, NJ
REASON The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)". The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.
VOLUME OF PRODUCT IN COMMERCE 209
DISTRIBUTION Nationwide and Internationally

PRODUCT Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322, 
CODE Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN,
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. 
REASON The lower detection limit (LDL) may be a higher value than stated in the labeling.
VOLUME OF PRODUCT IN COMMERCE 4,735 units
DISTRIBUTION Nationwide

PRODUCT CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use),
CODE Lots 469A and 475A; exp. 6/30/2008
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN
REASON The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
VOLUME OF PRODUCT IN COMMERCE 10 packs
DISTRIBUTION Nationwide

PRODUCT
a) Vaxcel Implantable Vascular Access System -Titanium Standard Port
With 9F Polyurethane Catheter, Catalog/REF No. 45-315,
UPN/Material No. M001453150, Single Use Only, STERILE, EO.
The port is provided as a kit, with various single use, disposable items
necessary for achieving vascular access and implanting the port catheter.
Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid.
This inner tray is then placed in a second outer plastic (PETG) tray, along
with the Directions for Use, and also sealed with a tyvek lid which is then labeled.
The port kit is placed in a cardboard carton, with additional labels and sealed,
b) Vaxcel Implantable Vascular Access System - Plastic Standard Port
With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material
No. M001453600, Single Use Only, STERILE, EO. The port is provided
as a kit, with various single use, disposable items necessary for achieving
vascular access and implanting the port catheter. Each kit is provided in
a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then
placed in a second outer plastic (PETG) tray, along with the Directions for
Use, and also sealed with a tyvek lid which is then labeled. The port kit is
placed in a cardboard carton, with additional labels and sealed,
CODE
a) Lots 1103350 and 1113798;
b) Lots 1109717 and 1120230
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Glens Falls, NY
REASON Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)
VOLUME OF PRODUCT IN COMMERCE 27 units
DISTRIBUTION NY, CA, MD, WA, and TN

PRODUCT VITROS® Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD, 
CODE Lots 6000 and 6030 thru 6120
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Cardiff, UK
REASON Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.
VOLUME OF PRODUCT IN COMMERCE 15,886 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Biohorizons 0.035 Hex Driver, REF 300-377, non-sterile, Rx only, REF 300-377, non-sterile, Rx only, 
b) Biohorizons 0.050 Hex Driver, Regular, REF 300-350, non-sterile, Rx only,
c) Biohorizons 0.050 Hex Driver, Long, REF 300-351, non-sterile, Rx only,
CODE
a) Lot No 09040003;
b) Lot No. 06060009;
c) Lot No. 08060239
RECALLING FIRM/MANUFACTURER BioHorizons Implant Systems, Inc., Birmingham, AL
REASON Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
VOLUME OF PRODUCT IN COMMERCE1,294 units
DISTRIBUTION Nationwide and Internationally

PRODUCT 1,25-Dihydroxyvitamin D RIA Kit. For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma, Part #65100E, 
CODE Lot's: 117139, 117140, 1117141
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN, REASON Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid).
VOLUME OF PRODUCT IN COMMERCE 715 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials, 
b) Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials,
CODE
a) Lot# 522202;
b) Lot# 509102
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mega Diagnostics, Los Angeles, CA,
Manufacturer: Pointe Scientific, Inc., Canton, MI. 
REASON Potential for microorganism growth in the alcohol standard.
VOLUME OF PRODUCT IN COMMERCE18 units
DISTRIBUTION Indonesia

PRODUCT DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples), 
CODE Lot # 118532
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN, REASON Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay).
VOLUME OF PRODUCT IN COMMERCE 100 kits
DISTRIBUTION UT, CO, IN, NC, CA, FL, Canada, Spain, Germany, Belgium and Italy

WEEK ENDING APRIL 28

ResMed Issues a Recall for Certain 58 Flow Generators

ResMed is recalling approximately 300,000 of its early production S8 flow generators used for the treatment of obstructive sleep apnea. In S8 devices manufactured between July 2004 and May 15, 2006, there is a remote potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator.

Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement.

The recall includes the following serial number ranges for all S8 models:

From

To

20040285613

20060269563

20060275728

20060276751

20060277160

20060277415

20060281672

20060281991

20060283424

20060283743

20060284896

20060285445

20060287568

20060290823

20060292360

20060294694

20060312361

20060312597

20060318692

20060319459

20060325074

20060327794

20060330588

20060331043

ResMed's S8 flow generators are distributed through medical equipment suppliers throughout the world. Affected products can be identified by the serial numbers on the bottom of each device. ResMed is working in close partnership with its distribution partners and the medical community to ensure that patients are fully aware of the replacement program and that patients who have an affected device will receive a replacement S8 flow generator.

Patients will be contacted as soon as possible to arrange for a replacement device and are encouraged to visit http://www.resmed.com/en-us/s8program/s8program.html for more information. Patients in the U.S. and Canada may also contact the ResMed S8 Replacement Call Center at 888-899-8991. Contact information for patients in Latin America, Europe and Asia Pacific is available at www.resmed.com/s8program.

PRODUCT
a) DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder, 
b) 535D-X CF Continuous Flow Cylinder, 
CODE
a) Model PD1000A-M4, serial numbers 06AM4111006 through 06AM4111055;
Model PD1000A-M6, serial numbers 06AM6111008 through 06AM6114328;
Model PD1000A-ML6, serial numbers 06AML111006 through 06AML111922;
Model PD1000A-C, serial numbers 06AC0111001 through 06AC0111191;
Model PD1000A-D, serial numbers 06AD0111011 through 06AD0111132;
and Model PD1000A-E, serial numbers 06AE0111006-06AE0111267;
b) Model 535D-M6-CF, serial numbers 06195A051 through 06276B225;
Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196;
Model 535D-C-CF, serial numbers 06230A008 through 06230A124;
Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and
Model 535D-E-CF, serial numbers 06230A055 through 06313B122
RECALLING FIRM/MANUFACTURER Sunrise Medical, Somerset, PA, 
REASON Cylinder could lose oxygen at high pressure after the filling process
VOLUME OF PRODUCT IN COMMERCE 4,169 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Mobilett XP, mobile X-ray system, Model number 1818454, 
b) Mobilett XP, mobile X-ray system, Model number 1818447, 
c) Mobilett XP, mobile X-ray system, Model number 1818363,
CODE
a) Serial numbers 1109, 1153, 1205, 2128, 1075, 1315, 1316, 1335,
1130, 1281, 1282, 1176, 1339, 1224, 1301, 2008, 1021, 1154,
1180, 1181, 1009, 1189, 1211, 1212, 2003, 2010, 1341, 1342,
2049, 2077, 2108, 1314, 1334, 1192, 1213, 1043, 1126, 1135,
2047, 2090, 2123, 1024, 1031, 1034, 1035, 1111, 2004, 1113,
1178, 1240, 1261, 2040, 1058, 1115, 1159, 1203, 1247, 1309,
1345, 2032, 1010, 1049, 1151, 1297, 1298, 2051, 1206, 1218,
1238, 1332, 1333, 2034, 2035, 2065, 1138, 1299, 1300, 2020,
2021, 2022, 2052, 2017, 2027, 1086, 1029, 1145, 1027, 1164,
1234, 2115, 1110, 1152, 1156, 1235, 1089, 1022, 1241, 1254,
1286, 1073, 1079, 1084, 1131, 1165, 1208, 2028, 2120, 2124,
2132, 1037, 1045, 1185, 1251, 1252, 1259, 1294, 1295, 2048,
1025, 1087, 1146, 1173, 1186, 1187, 1198, 1199, 1258, 1275,
1307, 2009, 1042, 1060, 1076, 1092, 1228, 1229, 1230, 1231,
1239, 1246, 1078, 2080, 2109, 2113, 1088, 1103, 1049, 1040,
1055, 1059, 1090, 1177, 1204, 1210, 1214, 1216, 1263, 1284,
1285, 1289, 1290, 1306, 1308, 2029, 2041, 2042, 2075, 2099,
2110, 1023, 1050, 1267, 1336, 1277, 1278, 1279, 1280, 2093,
1028, 1080, 1217, 1349, 1136, 1137, 1143, and 2100;
b) Serial numbers 2033, 1034, 1010, 1020, 1041, 1053, 2044, 2045,
1008, 1043, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032,
1033, 1040, 2007, 1052, 2001, 1017, 2002, 2040, 2021, 2022,
1011, 1016, 1018, 1021, 1039, 1054, 2005, and 2017;
c) Serial numbers 1035, 1038, 1051, 1052, and 1056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA.
Manufacturer: Siemens MED FG, Getafe-Madrid, Spain. 
REASON Mounting bolts for tank fork assembly and collimator flange may become loose.
VOLUME OF PRODUCT IN COMMERCE 227 units
DISTRIBUTION Nationwide

PRODUCT
a) RITA® Starburst™ XL (3-5 cm Diameter/25cm Length),
Electro-surgical Device, 
b) RITA® StarBurst™ (2-3cm Diameter/25cm Length),
Electro-surgical Device, 
c) RITA® Starburst™ MRI SemiFlex (3-5 cm Diameter/25cm Length),
Electro-surgical Device, 
CODE
a) Part number: 700-101317, Lot number: 22330, 22793, 23297, 23306,
24413, 24655, 25120, 25355, 25425, 25545, 25546, 25547, 25632,
25747, 25748, 25806, 25807, 25808, 25850, 25851, 25876, 25940,
25941, 25971, 25979, 25980, 25981, 26145, 26146, 26456, 26457,
26458, 26496, 26555, 26556, 26581, 26663, 26664, 26930, 26931,
26986, 26987, 27068, 27158, 27168, 27326, 27401, 27437, 27554,
27555, 27711, 27818, 27874, 28189, 28200, 28314, 28462, 28471,
28474, 28556, 28557, 28578, 28635, 28636, 28637, 28709, 28902,
28903, 28965, 28967, 28979, 29041, 29052, 29153, 29250, 29277,
29278, 29426, 29542, 29543, 29670, 29775, 29793 and 29794
Part number 700-101317J (Japanese distribution), Lot numbers 26714,
26715, 27327, 27328, 27329, 27526, 27626, 27969, 28084, 28190,
and 28250;
b) Product number: 700-101493, Lot number: 22442, 25551, 26583,
26937, 27439, 27807 & 29778 and
Product number: 700-101493J (Japanese distribution), Lot number: 25599,
25640, 25641, 25642, 25982, 26718, 26719, 26805, 26806, 27045, 27177,
27716, 27717, 27808, 27809, 27941, 27959, 27960, 27975, 27976, 27977,
28436, 28437, 28438, 28518, 28519, 28520, 28521, 28522, 28523, 28524,
28558, 28582, 28583 & 28584;
c) Part number: 700-102615, Lot number: 22445, 24657, 24772, 24557,
24824, 24921, 25126, 25360, 25361, 25431, 25432, 25554, 25601, 25555,
25644, 25755, 25645, 25756, 25815, 25816, 25860, 25859, 25947, 25948,
26153, 26239, 26312, 26466, 25977, 25978, 26240, 26311, 26467, 26564,
26580, 26587, 26588, 26672, 26673, 26730, 26940, 26941, 26994, 27071,
27165, 27179, 27256, 27358, 27408, 27407, 27409, 27444, 27562, 27594,
27719, 27720, 27811, 27875, 27877, 27961, 27962, 27968, 28091, 28098,
28257, 28322, 28440, 28441, 28468, 28525, 28526, 28560, 28638, 28714,
28639, 28719, 28906, 28881, 28971, 28972, 29044, 29113, 29158, 29159,
29256, 29340, 29548, 29045, 29667, 29856 & 29969
RECALLING FIRM/MANUFACTURER Rita Medical Systems, Inc., Manchester, GA.
REASON The product may have a cracked tray which can compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE 5,103 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) PADPRO™ ADULT Radiotranslucent Pad w/Zoll® connector.
Defibrillation/Pacing/Cardioversion/Monitoring Electrodes,
REF/Catalog # 2516Z. RX ONLY. Made in the USA,
b) PADPRO™ADULT Radiotranslucent Pad w/Medtronic® connector,
REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/
Monitoring Electrodes. Made in USA, 
CODE
a) Lots: Y040605-1, Y040605-2, Y052605-4, Y120805-2, Y111605-3,
Y092805-6, Y010506-10, Y010506-9;
b) Lot: Y101105-4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conmed Corporation, Utica, NY,
Manufacturer: Katecho Inc, Des Moines, IA. 
REASON Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.
VOLUME OF PRODUCT IN COMMERCE 10,632 pairs
DISTRIBUTION Nationwide and Internationally

PRODUCT Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG), 
CODE All battery packs with part number 520-LIBAT4-2
RECALLING FIRM/MANUFACTURER Bio-Logic Systems Corp., Mundelein, IL,
REASON If the battery pack is installed into a Netlink Traveler unit incorrectly, a short in the wiring of the battery pack may occur and overheat the battery cells. This can cause the plastic overwrap material of the battery pack to melt and smoke.
VOLUME OF PRODUCT IN COMMERCE 130 battery packs
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX,
b) Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX,
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc., Rochester, NY,
Manufacturer: Promex Technologies, LLC, Franklin, IN.
REASON The cutter probe tip breaks during use.
VOLUME OF PRODUCT IN COMMERCE 45,875 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels, 
CODE Lot number S07A10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Miltex, Inc., York, PA,
Manufacturer: Kai Industries Co Ltd, Seki City, Gifu Prefecture, Japan. 
REASON Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex).
VOLUME OF PRODUCT IN COMMERCE 400 boxes
DISTRIBUTION Nationwide

PRODUCT DiSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum, 
CODE 3160240B/1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater MN,
Manufacturer: DiaSorin, S.p.A., Saluggia (VC), Italy. 
REASON A lot to lot inconsistency was noted on kits of ETI EBNA G.
VOLUME OF PRODUCT IN COMMERCE 203 units
DISTRIBUTION Nationwide and Canada.